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Prudent Prescribing: An Overview of Recent Federal and State Guidelines for Opioid Prescriptions

According to the Centers for Disease Control and Prevention (CDC), opioid prescription sales have increased by 300 percent since 1999 without an overall change in pain reported by patients.1 Providers began prescribing large quantities of opioids in the 1990s following suggestions by pharmaceutical companies and some clinicians that they could safely be used to treat common conditions, such as chronic back pain. In 2012, healthcare providers wrote over 259 million opioid prescriptions, or the equivalent of one bottle of pills for every adult in the United States.2

Claims that opioids could be used without risk of addiction have since been found to be false. According to CDC Director Thomas Frieden, prescription opioids are “just as addictive as heroin,” and prescribing opioids is a “momentous decision.”3 From 1999-2014, more than 165,000 individuals died from an opioid-related overdose in the United States.4 These alarming statistics reveal that opioid abuse is an increasingly serious public health issue. These same statistics, however, are spurring federal and state officials to take action. This article focuses on some of the recent federal and state attempts to combat the epidemic by changing opioid prescribing practices.

The U.S. Surgeon General, Vivek Murthy, has become an outspoken advocate for stemming the rising incidence of opioid abuse and addiction. In an August 2016 interview, Dr. Murthy asserted that “this is one of our greatest public health threats” and implored providers to sharpen their opioid prescription practices.5 That same month, Dr. Murthy released a letter to healthcare providers asking them to commit to fighting against the opioid crisis.6 Dr. Murthy called on providers to view addiction as a chronic illness, not a moral failing. The letter also urged providers to consult the recently-released CDC guidelines to gain a better understanding of safe and effective opioid prescription practices.

CDC Guidelines

In response to the rapid increase of opioid overdose deaths and insufficient guidance on opioid prescribing practices, in March 2016 the CDC issued opioid prescription guidelines for chronic pain7 (CDC Guidelines or the Guidelines) to assist primary care clinicians (physicians, nurse practitioners, and physician assistants), who prescribe roughly half of all opioid medications in the United States but have limited training in how to use them. Although voluntary, the CDC Guidelines are intended as a best practices tool to improve clinician knowledge and deter the overprescribing of opioids. The Guidelines clarify how providers should assess the benefits and risks of prescription opioids versus other treatment options. The Guidelines do not offer a one-size fits all tool but instead are intended as a flexible framework to encourage improved communication between providers and patients and to support informed clinical decision-making. Clinical trials evidence indicates that opioids can be effective in reducing pain and improving function when used for a short-term duration, but the Guidelines assert that there is limited evidence demonstrating that opioids can effectively control chronic pain over a long period of time. Of note, these Guidelines do not apply to patients who have had surgery, patients receiving cancer care, palliative or end of life care, or to minors (patients under the age of 18).

When healthcare providers consider prescribing opioids, the Guidelines advise them to consider three main principles:

Use opioids only when necessary. Healthcare providers should avoid using opioids as the first line of treatment for chronic pain. The CDC Guidelines suggest use of other effective non-pharmacologic treatments, such as exercise and cognitive behavioral therapy, as well as nonopioid pharmacologic treatments such as acetaminophen and antidepressants.

Prescribe the lowest effective dose when using opioids. The CDC Guidelines advise providers to adopt the practice of “start low and go slow.” 8 If opioid treatment is necessary, providers should consider using the lowest effective dose possible and increase dosage gradually in order to avoid misuse of opioids. Providers should prescribe only the minimum dosage that is sufficient to manage the chronic pain.

Use caution, and monitor patients closely. Providers can minimize risk of abuse by checking state prescription drug monitoring program (PDMP) databases and continually monitoring patients during opioid treatment.9

The CDC Guidelines group 12 recommendations for opioid prescription practices into three categories: (1) assessing when opioid treatment should be used or continued; (2) opioid selection, dosage, duration, follow-up, and discontinuation; and (3) identifying risks and addressing harms of opioid abuse. 10

Assessing When Opioid Treatment Should Be Used or Continued

Prescription opioids should not be the first line of treatment for chronic pain. In assessing a patient’s pain level and ability to function, providers should consider using a validated pain scale11 to determine whether opioids or other nonpharmalogic/nonopioid pharmalogic treatments should be administered. The CDC recommends that opioid prescriptions only be dispensed if the expected benefits for both limiting pain and increasing function are anticipated to outweigh the risks to the patient. Providers should talk with patients about their treatment plans and set realistic goals for pain and functional improvement based on individual diagnoses. Opioid therapy should be continued only if there is clinically meaningful improvement in these areas. If the risks of opioid treatment outweigh the benefits to the patient, providers should have an established plan to discontinue such treatment.

Opioid Selection, Dosage, Duration, Follow-up, and Discontinuation

If opioid treatment is the best option for the patient, providers should prescribe immediate-release opioids rather than extended release/long acting (ER/LA) opioids. In reviewing available clinical evidence, the CDC found that there is a higher risk of overdose among patients initiating treatment with ER/LA opioids 12 than among those who were first prescribed immediate-release opioids. Additionally, the CDC found no evidence suggesting that continuous, time-scheduled use of ER/LA opioids is more effective or safer than intermittent use of immediate-release opioids. 13

Providers should start with the lowest effective dose and gradually increase dosages if indicated. When prescribing opioids, providers should always use caution with any dosage and should carefully reassess evidence of the benefits and risks when considering an increase in dosage of greater than or equal to 50 morphine milligram equivalents (MME) per day. Providers either should avoid increasing dosage to an amount greater than or equal to 90 MME per day or carefully justify a decision to titrate to that dosage level.

In light of varying opinions on the recommended length of opioid treatment, 14 the CDC advises that three days or less generally is a sufficient amount of time for opioid prescriptions, while prescriptions lasting more than seven days should rarely be needed.

To determine the effectiveness of opioid treatment, providers should start to evaluate the benefits and harms to the patient within one to four weeks of starting the treatment regimen. In addition, providers should evaluate the benefits and harms of continued opioid treatment at least every three months, and more frequently if needed. If such evaluations lead providers to conclude that the benefits do not outweigh the harms, providers need to taper or discontinue dosages.

Identifying Risks and Addressing Harms of Opioid Abuse

During the course of treatment, providers should continually be evaluating risk factors indicative of potential misuse or abuse of opioids. Providers also should develop strategies to mitigate risk, including offering naloxone when factors that increase risk of overdose - such as a history of overdose, substance use disorder, higher opioid dosages, or concurrent benzodiazepine use - are present. Furthermore, providers should avoid prescribing opioids and benzodiazepines at the same time. Regularly consulting state PDMP 15 data can help providers determine whether patients are already receiving high opioid dosages or potential drug combinations that might pose a risk of overdose. Finally, providers should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients suffering from opioid use disorder.

At this time, it is difficult to determine what effect, if any, the CDC Guidelines will have on primary care providers’ prescribing practices. Although the Guidelines do offer clarifications on how to safely approach opioid prescribing, some physicians may find the Guidelines intimidating due to their length, the number of recommendations included, and the complexity of diagnosing and managing pain due to its subjective nature. With growing incidents of prescription opioid misuse and the professional risk prescribers can incur as a result, primary care providers may simply refer more patients to pain specialists instead of implementing changes in treating chronic pain. This, however, could result in unfair hurdles for patients who are experiencing legitimate, long-term pain if pain specialists in their geographic area are scarce or unavailable.

The Guidelines have not been universally well-received. Some medical organizations, such as the American Medical Association, the American Academy of Pain Medicine, and the American Academy of Pain Management have expressed concerns about the evidence on which the Guidelines were based and warn that implementation of the 12 recommendations may be difficult for some providers. 16

Federal Efforts to Counteract Opioid Abuse

Addressing opioid abuse has become a top a priority for the U.S. Department of Health and Human Services (HHS). In an issue brief released in March 2016, HHS outlines three areas to combat opioid abuse: (1) focus on opioid prescription practices; (2) expanded use and distribution of naloxone, which blocks the effects of opioids and therefore acts as an antidote to an opioid overdose; and (3) expansion of medication-assisted treatment to reduce opioid use disorders and overdose. 17 HHS is developing a targeted set of actions that will have the highest likelihood of producing clinically-meaningful outcomes, and it continues to coordinate with other agencies to ensure that these actions are effectively implemented. The Office of Disease Prevention and Health Promotion created a free online course 18 for healthcare providers offering strategies to help providers prevent opioid-related adverse drug events. Upon successful completion of the course, providers can earn Continuing Medical Education (CME) credit.

State Oversight of Opioid Prescription Practices

The states also have acknowledged the opioid crisis. In July 2016, 45 state governors signed the Compact to Fight Opioid Abuse. This compact charges governors with updating prescribing guidelines, requiring pain management continuing education for prescribers, improving monitoring of providers prescribing opioids, and increasing access to treatment and recovery services through state healthcare programs (e.g., Medicaid). 19 Forty-nine states, the District of Columbia, and Guam have legislation authorizing the creation and operation of a PDMP, and almost all currently are collecting data and reporting on it to authorized users. 20 Prescribers in 29 states are required to check PDMP databases before prescribing certain controlled substances or in workers’ compensation cases. 21

Some states also have enacted legislation establishing new rules and procedures for licensed providers who dispense or use prescription opioids. In March 2016, Massachusetts became the first state to pass legislation restricting opioid prescriptions to a seven-day supply for adult prescriptions for first time users and a seven-day overall supply limit for minors. 22 The new law requires providers to check the state PDMP before writing a prescription for a Schedule II or Schedule III narcotic. In addition, prescribers must meet CME requirements for effective pain management.

Other states have launched different initiatives to root out providers who may be overprescribing opioids. In 2016, the North Carolina medical board started a new program, “The Safe Opioid Prescribing Initiative” (Initiative), to help the state identify providers who may be improperly or recklessly prescribing opioids. 23 Under a newly-amended law, the North Carolina Department of Health and Human Services is authorized to release to the North Carolina Medical Board (NCMB) information maintained in the state’s PDMP identifying, and the NCMB may then investigate, those prescribers who: (1) fall within the top one percent of providers prescribing 100 MME per patient for each day; (2) fall within the top one percent of those prescribing 100 MMEs per patient per day in combination with any benzodiazepine and who are within the top one percent of all controlled substance prescribers by volume; or (3) have had two or more patient deaths in the preceding 12 months caused by opioid poisoning. Unlike the CDC Guidelines, due to limitations of the PDMP database, the Initiative will not distinguish oncologists, hospice providers, or end-of-life caregivers from other prescribers. However, all investigated prescribers may submit medical record documentation to demonstrate that their opioid prescribing habits are proper.

Conclusion

Providers can help stem the tide in the opioid epidemic by evaluating and improving their prescription practices in a variety of ways:

Even though the CDC Guidelines are nonbinding, providers should review them, along with any state requirements, and consider implementing or revising prescribing policies and procedures to align with the Guidelines’ recommendations and relevant state requirements.
Prescribers should review and update their medical record documentation practices as needed to assure that their documentation of patients’ pain symptoms and related factors adequately support decisions to prescribe opioids.
Primary care providers who regularly prescribe opioids should consider using HHS’s free interactive course to review and learn about effective and safe prescription practices.
To identify patients who are at high risk for opioid addiction, providers should regularly consult applicable PDMP systems to ensure that they are providing adequate prescriptions to their patients.
Overall, primary care and pain management providers should use caution when prescribing opioids and should regularly monitor the status of patients receiving opioid treatment.

***

Patricia A. Markus is a partner in the Raleigh, North Carolina office of Nelson Mullins Riley & Scarborough. Ms. Markus advises clients, including substance abuse treatment facilities, on a broad array of healthcare regulatory compliance and transactional matters, with a special focus on health information privacy, security, and technology issues. She currently serves on the Board of Directors of the American Health Lawyers Association. She may be reached attrish.markus@nelsonmullins.com.

Ashley L. Thomas is an attorney in the Raleigh, North Carolina office of Nelson Mullins Riley & Scarborough, where she works with healthcare industry clients on regulatory and transactional matters. Ms. Thomas is not yet admitted to practice law in North Carolina but is licensed in Illinois, Indiana and Missouri. She currently serves as the Co-Chair of the Science and Technology Committee for the ABA's Young Lawyers Division. She may be reached atashley.thomas@nelsonmullins.com.

1

This statistic is cited by the U.S. Surgeon General for the Turn the Tide Rx Campaign, available at http://turnthetiderx.org/.

2

Centers for Disease Control and Prevention, Vital Signs (July 2014) available athttp://www.cdc.gov/vitalsigns/opioid-prescribing/.

3

Sabrina Tavernese, C.D.C. Painkiller Guidelines Aim to Reduce Addiction Risk, The New York Times (March 15, 2016) available athttp://www.nytimes.com/2016/03/16/health/cdc-opioid-guidelines.html?_r=0.

4

See CDC Guideline for Prescribing Opioids for Chronic Pain (March 2016)available at https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm

A validated pain scale is an assessment tool that actually measures a patient’s pain intensity and not some other factor, such as anxiety.

12

ER/LA opioids include methadone, transdermal fentanyl, and extended-release versions of opioids such as oxycodone, oxymorphone, hydrocodone, and morphine.

13

The clinical evidence suggests that ER/LA opioids should be reserved for severe, continuous pain and should be considered only for patients who have received immediate-release opioids daily for at least one week. When an ER/LA opioid is prescribed, using one with predictable pharmacokinetics and pharmacodynamics is preferred to minimize unintentional overdose risk. In particular, the unusual characteristics of methadone and transdermal fentanyl make safe prescribing of these medications for pain especially challenging.

14

According to the CDC Guidelines, some organizations (the American Academy of Emergency Medicine and the New York City Department of Health and Mental Hygiene) have recommended prescribing three days or fewer of opioids, while another organization (the American College of Emergency Physicians Opioid Guideline Writing Panel) recommends prescribing seven days or fewer. Yet another organization, the Washington State Agency Medical Director’s Group, recommends prescribing no more than 14 days of opioids. Limiting the number of days for which opioids are prescribed also should minimize the need to taper patients off of opioids to prevent distressing or unpleasant withdrawal symptoms.

15

PDMPs are tools used by governments and public health officials to monitor prescription drug use and reduce prescription drug abuse and diversion. PDMPs collect, monitor, and analyze electronically transmitted prescribing and dispensing data submitted by pharmacies and dispensing practitioners. The data are used to support states’ efforts in education, research, enforcement, and drug abuse prevention. PDMPs generally are managed by states, districts, commonwealths, or territories of the United States.

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